WASHINGTON — Women in the United States having trouble conceiving the natural way now may use a new tool to help choose the lab-dish embryo most likely to result in a pregnancy.
The Food and Drug Administration cleared for sale Auxogyn Inc.’s time-lapse photography device that assists fertility doctors who typically eyeball embryos to pick the most viable ones for placing in the womb. The closely held Menlo Park, Calif.-based company’s Eeva System assesses the timing of important changes in embryos’ development to differentiate among ones that look equally healthy.
The cost of a single attempt to create a test-tube baby can reach $17,000 and women’s chances of giving birth after in-vitro fertilization are as low as 13 percent for women older than 40, according to the National Institutes of Health. In a clinical trial, the Eeva System boosted doctors’ chances of picking a viable embryo by 53 percent.
“It’s helpful beyond words,” Michael Glassner, division head of infertility for Main Line Health System in Pennsylvania, said in an interview. “It’s going to give more clarity to the patient. It’s going to give a higher pregnancy rate. The miscarriage rate goes down. It’s just going to change the field.”
Glassner has used the Eeva System on about 40 of his patients in the last two months as part of a clinical trial evaluating the device.
The Eeva System is based on research done at Stanford University that discovered early growth can predict the health of an embryo. The Eeva System ranks embryos with either a high or low score based on the development process.
The system was cleared under the FDA’s de novo process for first-of-a-kind devices with low-to-moderate health risks. The device was cleared for sale in the European Union in 2012 and Canada last year. Merck, based in Darmstadt, Germany, is licensed to sell the system in Europe and Canada. Auxogyn plans to market the Eeva System on its own later this year in the U.S., said Lissa Goldenstein, president and chief executive officer.
Auxogyn doesn’t have data on how the Eeva System affects women’s chances of getting pregnant though the company plans to collect it, she said.